Scientific programme

P06  Poster Session - May 4 - May 6
CURRENT TREATMENT OPTIONS - HYPOMETHYLATING AGENTS (AZACITIDINE, DECITABINE)

04-May-2017 08:00 17:00
 
 
Abstract: 046
STABLE DISEASE WITH HEMATOLOGIC IMPROVEMENT IS CLINICALLY MEANINGFUL FOR OLDER PATIENTS WITH ACUTE MYELOID LEUKEMIA (AML) TREATED WITH AZACITIDINE

Effects on overall survival (OS) are of primary importance when evaluating AML treatments. Complete remission (CR) rates are lower with azacitidine than with intensive chemotherapy, but OS is similar (Dombret, Blood, 2015). AML is a progressive disease; stable health status may reflect slowing of disease progression and may prolong survival. This post hoc analysis evaluated OS outcomes among patients with AML (>30% blasts) treated with azacitidine or conventional care regimens (CCR) in the phase 3 AZA-AML-001 study who had stable disease (SD) at 2-, 4-, and 6-month study landmarks. SD was protocol-defined as absence of IWG-defined response and no progressive disease (PD), regardless of whether hematologic improvement (HI) was attained. Patients with SD could have had a response or PD at any time other than at landmarks. OS was also evaluated in patients with HI as best response, beginning on or before, and sustained past, each landmark. 

At landmark assessments, median OS for SD patients ranged from 13.5–14.3 months with azacitidine vs 11.1–12.1 months with CCR, and estimated 1-year survival ranged from 59.2%–67.1% vs 44.4%–51.7%, respectively. Hazard ratios for OS with azacitidine vs CCR ranged from 0.81–0.88 and 1-year survival was ~15% higher with azacitidine at each landmark. Within treatment arms, azacitidine-treated patients with HI as best response had meaningfully improved OS vs no HI; however, HI with CCR did not largely influence OS (Figure; Table). Estimated 1-year survival for azacitidine-treated patients with HI was 4.9%–27.4% greater than without HI, but for CCR-treated patients was only 0%–10.3% greater. Between treatments, 1-year survival with azacitidine in patients with HI was 9.6%–33.3% greater than for CCR-treated patients with HI.

These data suggest that achieving and maintaining SD or HI is associated with relatively favorable survival outcomes. They also suggest that HI with azacitidine is qualitatively different from HI with CCR, as patients with SD and HI during early azacitidine treatment had meaningful improvements in OS, whereas similar CCR-treated patients did not. The prognostic relevance of HI in AML requires further study. 





 
Co-authors
A.C. Schuh 1, H. Döhner 2, J.F. Seymour 3,4, P. Turlure 5, C. Junghanss 6, A. MacWhannell 7, N. Tu 8, S. Songer 9, C.L. Beach 9, H. Dombret 10
1Princess Margaret Cancer Centre/University Health Network, Department of Malignant Hematology, Toronto, Canada
2Universitätsklinikum Ulm, Department of Internal Medicine III, Ulm, Germany
3Peter MacCallum Cancer Centre, Department of Haematology, Melbourne, Australia
4University of Melbourne, Department of Haematology, Parkville, Australia
5Centre Hospitalier Universitaire de Limoges, Department of Hematology, Limoges, France
6Universitätsmedizin Rostock, Department of Medicine III, Rostock, Germany
7The Royal Wolverhampton Hospitals NHS Trust, Department of Haematology, Wolverhampton, United Kingdom
8Celgene Corporation, Department of Biostatistics, Summit, USA
9Celgene Corporation, Department of Hematology/Oncology, Summit, USA
10Hôpital Saint Louis- Institut Universitaire d’Hématologie, Department of Hematology, Paris, France